1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
A prospective study on The additive effect of ursodeoxycholic acid on indirect hyperbilirubinemia in neonate under phototherapy
Protocol summary
Summary
Hyperbilirubinemia is a common problem during infancy.Typically, phototherapy is used for reducing bilirubin in neonates; however, it has
disadvantages.Therefore, the present study aims to investigate the effect of ursodeoxycholic acid on reducing the indirect bilirubin of the infants undergoing phototherapy; so that their lengths of phototherapy and hospitalization can be reduced. The present randomized clinical trial was conducted on the infants with
hyperbilirubinemia who were under treatment by phototherapy in the neonatal wards of the hospitals affiliated to Shiraz University of Medical Sciences, Shiraz ,IRAN. Study design is interventional, randomaized, single blind.The infants are randomly divided into two 40-subject. The first group which include 40 infants with hyperbilirubinemia receive 10-15 mg/kg/day q12h ursodeoxycholic acid, while the control group receive no medications and only underwent phototherapy. The inclusion criteria of the study are birth weight of 2500-4000 g; being exclusively breast fed; gestational age of 38-41 weeks; being above 3 days old; total bilirubin level of 14-20, and direct bilirubin level<2 mg/dL. On the other hand, the infants with hemolysis &
septicemia and the infants of diabetic mothers exclude from the study. Indirect bilirubin levels measure 2 time per day until the bilirubin level reache below 10 and phototherapy disrupte. The length of phototherapy measure using a timer. Finally the two groups are compared from the time bilirubin reache below 10, and length of phototherapy.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT2013020512370N1 Registration date: 2013-05-12, 1392/02/22 Registration timing: registered_while_recruiting
Last update:
Update count: 0 Registration date
2013-05-12, 1392/02/22 Registrant information
Name
Narjes Pishva
Name of organization / entity Shiraz University of Medical Sciences Country
Iran (Islamic Republic of) Phone
+98 71 1627 0182 Email address
ghashghaei@sums.ac.ir Recruitment status
Recruitment complete Funding source
Shiraz University of Medical Sciences
Expected recruitment start date 2012-12-21, 1391/10/01
Expected recruitment end date 2013-05-22, 1392/03/01 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
A prospective study on The additive effect of
ursodeoxycholic acid on indirect hyperbilirubinemia in neonate under phototherapy
Public title
A prospective study on The additive effect of
ursodeoxycholic acid on indirect hyperbilirubinemia in neonate under phototherapy
2 Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: birth-weight 2500-4000 gr; gestational age between 38-41 weeks; breastfeeding neonate; total bilirubin 14-20 mg/dl and neonates age older than three days. Exclusion criteria: infants with incompatible ABO, Rh; G6PD deficiency; direct hyper billirubinemia;
septicemia or diseases that are implicated in causing jaundice; premature infants; infants of diabetic mothers.
Age
From 3 years old to 28 years old Gender
Both Phase
N/A
Groups that have been masked No information
Sample size
Target sample size: 80
Randomization (investigator's opinion) Randomized
Randomization description Blinding (investigator's opinion)
Single blinded Blinding description Placebo
Not used Assignment
Parallel
Other design features
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
shiraz university of medical science Street address
shiraz university of medical scienc,zand street,shiraz City
shiraz Postal code
71438-14336 Approval date
2012-09-20, 1391/06/30
Ethics committee reference number CT-P-91-3827
Health conditions studied
1
Description of health condition studied Indirect hyperbilirubinemia in neonate ICD-10 code
P59.9
ICD-10 code description
Physiological jaundice (intense)(prolonged) NOS
Primary outcomes
1
Description
Duration of need phototherapy Timepoint
Since start study till finish study Method of measurement
Timer
Secondary outcomes
1
Description
Serum total bilirubin Timepoint
Since start study &12, 24, 36, 48 hour Method of measurement
Blood sample
Intervention groups
1
Description
First group was given ursodeoxycholic acid 10-15 mg/kg divided q12h before starting phototherapy till exclusion from study. In the first day, laboratory tests included estimation of total bilirubin (direct and indirect), blood group including rh of the mother and neonate, complete blood count (cbc), g6pD activity, coombs test,
reticulocyte count. Direct and indirect, as well as tsb were measured every 24 hours by the same laboratory till total serum bilirubin dropped under 10 mg/dl. The duration of phototherapy was recorded with a timer.
Category
Treatment - Drugs
2
Description
Second group that is control group received no medications and only underwent phototherapy.
Category N/A
Recruitment centers
1
Recruitment center
Name of recruitment center Hafez hospital
Full name of responsible person Ghashghaei Saadi Elham MD
3 Street address
Phototherapy ward, Hafez hospital, Chamran blud square, Daneshjo square
City Shiraz
Sponsors / Funding sources
1 Sponsor
Name of organization / entity Shiraz University of Medical Sciences Full name of responsible person
Hatam Gholamreza MD Street address
Shiraz University of Medical Science, Zand street, Shiraz
City Shiraz Grant name
ﯽﺗﺎﻘﯿﻘﺤﺗ یﺎﻫ حﺮﻃ ﻪﺟدﻮﺑ ﻒﯾدر Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences Proportion provided by this source
100
Public or private sector empty
Domestic or foreign origin empty
Category of foreign source of funding empty
Country of origin
Type of organization providing the funding empty
Person responsible for general inquiries
Contact
Name of organization / entity Shiraz University of Medical Sciences Full name of responsible person
Ghashghaei Saadi Elham MD Position
MD, resident of pediatric disease Other areas of specialty/work Street address
Pediatric office ward, Namazi hospital City
Shiraz Postal code
713451978 Phone
+98 71 1612 5477 Fax
elhamghashghaei @yahoo.com;
ghashghaei@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity Shiraz University of Medical Sciences Full name of responsible person
Honar Naser MD Position
Asistant professor of pediatric gasteroenterology Other areas of specialty/work
Street address
Namazi hospital pediatric office ward City
Shiraz Postal code
71345-1978 Phone
+98 71 1612 5477 Fax
+98 71 1647 4297 Email
honarr@sums.ac.ir Web page address
Person responsible for updating data
Contact
Name of organization / entity Shiraz University of Medical Sciences Full name of responsible person
Ghashghaei Saadi Elham MD Position
MD, resident of pediatric disease Other areas of specialty/work Street address
Pediatric office Ward, Namazi hospital City
Shiraz Postal code
713451978 Phone
+98 71 1612 5477 Fax
elhamghashghaei@yahoo.com;
ghashghaei@sums.ac.ir Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report
4 empty
Analytic Code empty
Data Dictionary empty
